Lisa Astor

“Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result."

A novel CD22-targeted/4-1BB product achieved a high complete response rate in patients with relapse or refractory CDD22-positive cancers.

"The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma."

FoundationOne CDx has been approved by the FDA as a companion diagnostic for pembrolizumab to identify patients with tumor mutational burden–high solid tumors who would benefit from this therapy.

"KEYNOTE-158 has confirmed clinical activity of pembrolizumab in tumors harboring a TMB ≥10 across a variety of solid tumors including anal, biliary, cervical, endometrial, mesothelioma, neuroendocrine, salivary, small cell lung, thyroid, and vulvar cancers."

"This interim analysis demonstrated ropeginterferon in low-risk patients is more efficacious in keeping the hematocrit [at target levels]. In addition, we get a better quality of life and the target was reached with a reduction of phlebotomy needs."

"We believe DKN-01 has the potential to be an important new therapy for this patient population that remains an area of high unmet medical need."

"While we are disappointed in these study results, Keytruda has been established as an important option in the treatment of metastatic bladder cancer, and we are committed to continuing our research to help more patients with this disease."

“Due to a lack of efficacy observed with lenvatinib monotherapy in anaplastic thyroid cancer, further investigation of lenvatinib in combination with a checkpoint inhibitor may be warranted rather than pursuing further lenvatinib as a single agent.”

The FDA has granted margetuximab an orphan drug designation for the treatment of patients with gastric and gastroesophageal junction cancer.

"Selpercatinib had marked intracranial anti-tumor activity in RET fusion–positive patients with [NSCLC and] CNS metastases. Tumor responses were durable, independently confirmed, and observed in patients with prior systemic chemotherapy."

"The ARROW trial results presented today during the ASCO virtual meeting showed that patients with RET fusion–positive lung cancer treated with the selective RET inhibitor pralsetinib had durable responses. In addition to supporting the development of pralsetinib across a broad population, these data highlight the urgency to test [patients with] lung cancer with next-generation sequencing so that eligible patients may be identified for treatment."

"The CONDOR study met its primary endpoint. Indeed, it well exceeded it. And it demonstrated excellent diagnostic performance of PyL PET in men with biochemically relapsed prostate cancer, even at very low PSA values."

The FDA has approved ramucirumab in combination with erlotinib for the first-line treatment of patients with metastatic non–small cell lung cancer harboring EGFR exon 19 deletions or exon 21 mutations.

The addition of tucatinib to treatment with trastuzumab and capecitabine resulted in more than a 60% reduction in the risk of central nervous system progression or death in both patients with previously treated HER2-positive metastatic breast cancer who have active or stable brain metastases.

“Preliminary data for the 18 patients who have received belantamab mafodotin 2.5 mg/kg single dosing with bortezomib/dexamethasone suggests that this combination has an acceptable safety profile with no new safety signals identified. Clinical response looks promising."

"Prior administration of chemotherapy is associated with increased risk of death [from COVID-19] while immunotherapy and tyrosine kinase inhibitors are not."

“Although these are early data, we are encouraged by these findings. The depth of response is particularly impressive in some patients."

Nivolumab plus ipilimumab in combination with chemotherapy was granted approval for the frontline treatment of patients with metastatic or recurrent non–small cell lung cancer who do not harbor EGFR or ALK genomic tumor abberations.

The FDA has approved olaparib for the treatment of patients with metastatic castration-resistant prostate cancer who have deleterious or suspected deleterious germline or somatic HRR gene mutations and have progressed following prior treatment with a new hormonal agent.

"Today’s news is very welcome as we continue to evaluate the potential of Enhertu to help patients with this devastating type of lung cancer. Targeted treatments and immunotherapies are demonstrating tremendous advancements, but there remains an unmet medical need for patients with HER2 mutations who are not benefiting from such therapies or for those whose cancer continues to progress."

"These interim data demonstrate that primary chemoablation of low-grade intermediate-risk non–muscle invasive bladder cancer using UGN-102 results in a significant treatment response and encouraging durability."

"Rucaparib’s approval could have a profound impact on patients with BRCA2 and BRCA1 mutations, who have no other targeted treatment option available to them based on this mutation."

The combination of the combination of nivolumab and ipilimumab is now approved by the FDA for the treatment of metastatic or recurrent non–small cell lung cancer with PD-L1 expression greater than 1%...

“In the final SOLO2 analysis, maintenance olaparib provided a clinically meaningful improvement of 12.9 months [in] median overall survival. These results demonstrate that olaparib maintenance monotherapy not only delays disease progression but also improves overall survival in women with platinum-sensitive ovarian cancer and a BRCA mutation.”

"These results have the potential to substantially move the field forward and represent an important step toward making stem cell transplantation more accessible and more successful for patients with lethal blood cancers. Shortening the time to engraftment is clinically meaningful, as it can reduce a patient’s time in the hospital and decrease likelihood of infection."

The FDA has approved selpercatinib capsules for the treatment of patients with lung cancer or thyroid cancer harboring RET alterations. This marks the first treatment approved to target RET gene alterations.

The FDA granted approval to the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab and whose cancer is associated with homologous recombination deficiency–positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

“Immune transcriptomic analyses of in silico and wet-lab cohorts of TP53-mutated AML suggest the presence of high T-cell infiltration and high expression of immune checkpoints and interferon-gamma signaling molecules compared with AML subgroups with other risk-defining molecular lesions."

"The acceptance of our submission for CC-486 represents an important step towards a potential new maintenance treatment to address an urgent medical need for patients with AML and we look forward to working with the FDA during its review of CC-486."